NeuVax + Herceptin

NASDAQ: GALE
www.galenabiopharma.com
1
Forward Looking Statements
This presentation contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Such statements
include, but are not limited to, statements about the future expectations,
plans and prospects for the development and commercialization of the
Company's products and are subject to a number of risks, uncertainties and
assumptions, including those identified under “Risk Factors” in the
Company’s most recently filed Annual Report on Form 10-K and Quarterly
Report on Form 10-Q and in other filings the Company periodically makes
with the SEC. Actual results may differ materially from those contemplated
by these forward-looking statements. The Company does not undertake to
update any of these forward-looking statements to reflect a change in its
views or events or circumstances that occur after the date of this
presentation.
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Galena Biopharma: Summary
q 
Biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major unmet
medical needs to advance cancer care
q 
Revenue generating in 2013 with launch of Abstral® (fentanyl) Sublingual
Tablets approved for breakthrough cancer pain
q 
NeuVax™ (nelipepimut-S) is a novel cancer immunotherapy which
targets the HER2 protein, with promising Phase 1/2 clinical results
q 
q 
Ø 
Phase 3 PRESENT multicenter, multinational trial of 700 patients with SPA ongoing
in HER2 IHC 1+/2+ low-to-intermediate, node positive, adjuvant breast cancer
patients
Ø 
Phase 2b NeuVax + Herceptin® (trastuzumab) combination trial in 300 node
positive and negative adjuvant breast cancer patients
GALE-401 (Anagrelide CR) is a patented controlled release formulation
of anagrelide that will use the 505 (b)2 regulatory pathway to seek
approval for Essential Thrombocytemia.
Ø 
Multiple Phase 1 studies in n=90 patients demonstrated that GALE-401 reduces
Cmax by ~70% and delivers 100% of AUC
Ø 
Dose-dependent reduction in platelets
GALE-301 (Folate Binding Protein (FBP)) is a novel immunotherapy for
patients with ovarian and endometrial cancer in Ph 2
Galena Biopharma: Product Pipeline
Product(&(Candidate
Abstral®((fentanyl)(
Sublingual(Tablets
TM
NeuVax ((nelipepimutHS)
Indication
IND
Phase(1
Phase(2
Phase(3
NDA
Approved
Breakthrough+Cancer+Pain+
(BTcP)
Breast+Cancer
TM(
NeuVax +(Herceptin®(
(trastuzumab)
TM
Breast+Cancer
NeuVax ((nelipepimutHS)
Gastric+Cancer
GaleH401((Anagrelide(CR)
Essential+
Thrombocythemial+(ET)
GaleH301((Folate(Binding(
Protein((FBP))
Ovarian+&+Endometrial+
Cancer
!!!!!Approved!
!!!!!In!Progress!
!!!!!Planned!
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Collaborations
Product
Abstral® (fentanyl)
Sublingual Tablet
Target
Clinical /
Regulatory
Collaboration
U.S. ownership acquired from
Breakthrough cancer pain
FDA-Approved
Gastric trial & India
commercialization
NeuVax™
(nelipepimut-S)
Node positive HER2 negative
breast cancer (low-tointermediate expression, IHC
levels of 1+ or 2+ and a FISH
rating of less than 2.0)
Phase 3
PRESENT Trial
under FDAapproved SPA
Israel
Commercialization
Companion
Diagnostic
Korea
Commercialization
NeuVax™ +
Herceptin®
(trastuzamab)
Node positive HER2 negative
breast cancer (low-tointermediate expression, IHC
levels of 1+ or 2+ and a FISH
rating of less than 2.0)
GALE – 201
Folate Binding
Protein (FBP)
Endometrial and ovarian cancer
Clinical Collaboration
Phase 2b
Phase 2
Commercial
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Abstral® (fentanyl) Sublingual Tablets
Approved for Breakthrough Cancer Pain (BTcP)
" 
Galena acquired U.S. rights in
Mar-2013
§ 
Market leader in Europe with $54M sales
by ProStrakan/Kyowa Hakko Kirin;
marketed in Canada by Paladin Labs;
approved in Japan by Kyowa Hakko Kirin.
" 
Q4 2013 product launch into ~
$400 MM market
" 
The innovative Abstral
formulation:
ü 
Delivers the analgesic power and
increased bioavailability of micronized
fentanyl in a more convenient sublingual
tablet which rapidly dissolves under the
tongue in seconds,
ü 
Provides rapid relief of breakthrough
pain in minutes, and;
ü 
Matches the duration of the entire pain
episode.
Please see full prescribing information at www.abstral.com
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Abstral for Breakthrough Cancer Pain
" 
Cancer pain is caused by damage to
body tissues related to disease activity
(e.g., tumors pressing on nerves) or by
treatments (e.g., surgery, chemo,
radiation).
" 
Abstral® (fentanyl) Sublingual
Tablets are an important treatment
option for inadequately controlled
breakthrough cancer pain (BTcP)
which:
q 
BTCP episodes can last anywhere from
several seconds to hours with the
average episode lasting 30 or so
minutes.
q 
Occurs in approximately 1/3 of patients
being treated for cancer and up to 80%
of patients with later stage disease.
q 
May happen anytime and anywhere
during the disease process. It is not
just an end of life issue.
Sources: Paice, et al. Cancer Pain (2011); MA, Müller-Schwefe GHH. Curr. Med. Res. Opin. (2011);27:1385-94; Portenoy RK,
Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41(3):273-281; 5. Bennett D, Burton AW,
Fishman S, et al. Consensus panel recommendations for the assessment and management of breakthrough pain: part I
assessment. Pharm Ther. 2005;30(5):296-301.
Please see full prescribing information at www.abstral.com
8
Mean Pain Relief over time for BTcP episodes
treated with Abstral and placebo
Source: Rauck RL et al. Curr Med Res Opin 2009; 25(12): 2877-2885
Please see full prescribing information at www.abstral.com
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Daily Supply of Abstral v. Leading Competitor
Please see full prescribing information at www.abstral.com
The majority of patients preferred Abstral
over their previous BTcP medication(s)
Source:Überall M, Müller-Schwefe GHH. Curr Med Res Opin 2011; 27(7): 1385-1394.
Please see full prescribing information at www.abstral.com
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Cancer
Immunotherapy
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NeuVax contains the immunodominant peptide derived
from the extracellular region of the HER2 protein
(nelipepimut-S)
•  Stimulates HER2 Directed CD8+ Killer T cells
•  Off-the-shelf peptide (aa 369-377) cancer
immunotherapy
•  MHC Class I: HLA A2/A3
KI FGSLAFL
13
NeuVax (nelipepimut-S) Development
Approach: Focus on minimal disease (adjuvant)
setting to prevent breast cancer recurrence
q 
25% of resectable node-positive breast cancer
patients, despite having no evidence of disease
following surgery and chemo/radiation therapy,
will still relapse within 3 years.
q 
Increased presence of circulating tumor cells
(CTC) predict DFS and OS--suggesting a
dormancy of isolated micrometastases which
over time, leads to recurrence.
q 
NeuVax elicits a robust, specific and durable
killer CD-8 Cytotoxic T Lymphocyte (CTL)
response to lyse HER2 expressing tumor cells.
NeuVax binds to antigen expressing cells
(APCs) (in green). NeuVax stimulated APCs
activate CD8+ cytotoxic T lymphocytes (CTLs)
(in blue) which rapidly replicate to seek out
and destroy Her 2 expressing tumor cells and
micro-metastases.
Sources: Giordano et al. Is breast cancer survival improving? Cancer. 2004;100:44-52; Saphner et al. Annual hazard rates of
recurrence for breast cancer after primary therapy. J Clin Oncol. 1996; 14: 2738-2746; Lucci et al. Circulating tumor cells
in non-metastatic breast cancer: a prospective study. The Lancet Oncology. Jul 2012; 13(7): 688-695.`
14
Recurrence Hazard Rates Are Dependent
on Known Prognostic Factors
Hazard of recurrence by yearly interval
Prominent early peak of recurrences (~ 3 yrs)
in absence of adjuvant therapy, particularly in ER- disease
25
Total
Node 0
20
Node 1-3
Node (4+)
15
Tumour size (<1cm)
Tumour size (1.1-3cm)
10
Tumour size (>3cm)
ER+
5
ERPremen
Postmen
0
0.5
1.5
2.5
3.5
4.5
5.5
6.5
7.5
8.5
9.5 10.5
Year
Source: Early Breast Cancer Trialists’ Collaborative Group. Lancet. 1998;351:1451 ; Update of Houghton. J Clin Oncol.
2005; 23(16S):24s. Abstract 582 Saphner et al., J Clin Oncol. 14: 2738-2746, 1996
15
Presence of Circulating Tumor Cells (CTCs) is an independent
predictor of relapse and mortality in non-metastatic breast cancer
Brain
Lymph
nodes
Pleura
Skin
Liver
Lung
Bone
Source: Lucci et al. Circulating tumour cells in non-metastatic breast cancer: a prospective study. The
Lancet Oncology. Jul 2012; 13(7): 688-695.
16
NeuVax (nelipepimut-S) Phase 1/2 Trials (n=187)
NeuVax (nelipepimut-S)
Enrollment
n=195
6 withdrew and 1 lost to
follow up prior to starting
trial; 1 excluded
Total Evaluable
n=187
Node Positive
(SN-33)
N=97
Vaccine
HLA-A2/A3+
n=53
Control
HLA-A2/A3n=44
Node Negative
(SN-34)
N=90
Vaccine
HLA-A2/A3+
n=55
Control
HLA-A2/A3n=35
17
Local & Systemic Toxicity is Minimal:
Node-Negative & Node-Positive Patients
100%
82%
72%
% of Patients
75%
Local
Local
Systemic
Sytemic
50%
25%
18%
13%
0%
11%
0%
Grade 0
0%
Grade 1
Grade 2
4%
Grade 3
0% 0%
0% 0%
Grade 4
Grade 5
18
SN-33 Phase 1/2 Intent-to-Treat at 60 mos (n=97)
ITT patients in this phase 1/2 trial favored VG in DFS at 24 months (VG 90.6%, CG 79.5%, p=0.1194); at
60 months, the VG continues to have fewer recurrences than the CG (VG 84.7% vs. 77.1%)
NeuVax (nelipepimut-S) Booster Series
Immunologic Response
3.50 3.00 R² = 0.84944 Dimer response 2.50 2.00 1.50 1.00 0.50 0.00 Pre Post B1 B1 (n=53) Pre Post B2 B2 (n=34) Pre Post B3 B3 (n=24) Pre Post B4 (B4 n=20) Booster Inocula2on Pre Post B5 (B5 n=12) Pre Post B6 B6 (n=8) 20
SN-33 Phase 2 HER2 IHC 1+/2+ (N=45)
When the HER2 positive patients were removed from the population, the Phase 2 HER2 IHC 1+2/+ VG
had a significantly improved DFS at 24 months (100% vs. 77.8%, p=0.035); at 60 months, VG retains a
20.3% difference (VG 94.4% vs. CG 74.1%).
NeuVax Ph 2 Conclusions
§  NeuVax (nelipepimut-S) elicits strong HER2 directed immunity
§ 
Well–tolerated
§ 
Demonstrates dose response
§ 
Booster series increases anti-tumor activity and maintains immune
response over time
§  At the end of the 5 year follow-up period, NeuVax
demonstrated a statistically significant increase in Disease
Free Survival (DFS)
§  Phase 3 target patient population defined: node positive, HLA A2/3,
HER2 IHC 1+/2+ or low to intermediate patients.
§  Phase 3 FDA approved SPA (Special Protocol Assessment)
established primary endpoint as 36 month DFS
22
NeuVax: Phase 3 PRESENT Trial per SPA
Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with
Low to Intermediate Her2 Expression with NeuVax Treatment
Interim analysis
Endpoint DFS at
by DSMB at
n=142 events/36 mos.
n=70 events
+ GM-CSF
Study Popula2on 700 adjuvant breast cancer
patients, randomized 1:1
§  Double blind
§  Node positive
§  HLA A2/A3+
Placebo + GM-CSF
§  HER2 IHC 1+/2+
§  Stratified by stage, type of
surgery, hormone receptor,
and menopausal status
Dosing by Month
1
2
3
4
5
6
+ 1 booster
dose every 6
months
thereafter
+ Dosing to disease
progression or 36
months
23
Ph 2a: NeuVax + Herceptin® (trastuzumab)
Adjuvant Immunotherapy (24 mos)
" 
"
Preclinical data demonstrated
synergy of combining
trastuzumab and NeuVax by
enhancing tumor antigen
presentation
Ph 2a compared NeuVax and
trastuzumab (Herceptin) v
trastuzumab alone:
§ 
§ 
n=32 trastuzumab
monotherapy recurrence rate =
12.5% (4/32)
n=30 trastuzumab + vaccine
recurrence rate = 0% (0/30)
HER2/neu –derived peptide
presented on MHC-I
Trastuzumab
HER2/neu
Breast
tumor cell
HER2/neuderived
peptide
Trastuzumab/HER2 complexes are internalized and
processed by proteasomes into short peptides which are
then presented on MHC class I molecules.
Source: Sears et al. J Clin Oncol; 29:2011 (suppl; abstr 564); Source: Mittendorf EA, et al (2006. Ann
Surg Oncol;13:1085-98.
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NeuVax + Herceptin: Phase 2b Trial
Primary
Endpoint DFS
at 24 mos.
Secondary
Endpoint DFS
at 36 mos.
Study Popula2on 300 adjuvant breast cancer
patients, randomized 1:1
§  Single blind (subject)
§  Node positive or negative
§  HLA A2/A3+
§  HER2 negative 1+/2+
+
§  Stratified by nodal status
and HER2 status
§  First patient enrollment in
1H, 2013
Standard of Care: Standard Herceptin
dosing every 3 weeks for 1 year
6 doses of NeuVax given every 3
weeks starting with third dose of
Herceptin
+ 1 booster
dose every
6 months
thereafter
+ Dosing to
disease
progression
or 36 months
25
NeuVax: Significant Market Opportunity
Newly Diagnosed Breast Cancer
Patients Annually:
~230,000 in US(1) ~450,000 in EU(2)
HLA A2/A3(3)
(75%)
HER2 1+/2+(4)
(50-60%)
Node Positive(5)
(30-40%)
U.S. = 30,000 – 40,000
EU = 50,000 – 80,000
Addressable Node
Positive Population
Sources: (1)American Cancer Society 2011 Breast Cancer Facts and Figures; WHO; (2)TD. Distribution of HLA antigens in North
American Caucasians, North American Blacks and Asians; (3)Slamon DJ, et al. Science 1987;235:177-82; (4)Intl Journal of Breast
Cancer Volume 2011, Review Article: A. Pazaiti & Ian S. Fentimen
26
GALE-301 (Folate Binding Protein (FBP))
targeted cancer immunotherapy
40
E39 DTH Response (mm)
" 
FBP is over-expressed
(20-80 fold) in >90% of
ovarian and endometrial
cancers.
" 
FBP has very limited tissue
distribution and expression
in non-malignant tissue
making it an ideal
immunotherapy target.
" 
Status: Phase 1 complete.
Phase 2 initiated Q1 14.
35
30
25
20
15
10
5
0
Pre-Vaccine
Post-Vaccine
27
Hematology
28
GALE-401 (Anagrelide CR)
• 
GALE-401 (Anagrelide CR) being developed to treat Essential
Thrombocythemia (ET).
• 
ET is an acquired disease of the bone marrow, characterized by highly
elevated platelet counts which increases the risk of thrombotic events.
• 
• 
Active ingredient anagrelide immediate release (IR) (Agrylin®; Shire) in use
since late 1990s for the treatment of ET.
§ 
" 
Orphan disease with 8K incidence; and 80-100K prevalence
Despite several advantages over HU and demonstrating non-inferiority, the Cmaxrelated side effect profile of anagrelide immediate release has largely limited the drug
to second line use.
GALE-401 is a patented controlled release formulation of anagrelide that
will use the 505 (b)2 regulatory pathway to seek approval for ET.
§ 
Multiple Phase 1 studies in n=90 patients demonstrated dose-dependent platelet
reduction, while reducing Cmax by ~70% and delivering 100% of AUC.
§ 
Target product profile is increased tolerability vs anagrelide IR while maintaining
efficacy, thus allowing more patients to achieve target platelet levels; and potentially
enabling treatment expansion to larger and younger patient populations.
29
Essential Thrombocythemia (ET) is a neoplastic stem
cell disorder causing dysregulated production of
large numbers of abnormal platelets
Normal Peripheral Smear
Normal platelet count:
150 – 450 x 103/uL
30
Essential Thrombocythemia
(ET) —Note Large Number and
Size of Platelets
Platelet count: 1 - 5 x 106/uL
30
Phase 1: GALE-401 (Anagrelide CR) vs IR
Novel ANA-CR Formulation Maintains 100% of AUC While Reducing Cmax by 70%
31
31
Phase 1: GALE-401 (Anagrelide CR) PK
with Multiple Dose Comparisons
CR
(GALE-401)
IR
(Agrylin)
Ratio
CR : IR
Cmax
(pg/mL)
633
2210
29%
AUC0-t
(pg*h/mL)
4409
5456
81%
AUC0-inf
(pg*h/mL)
5543
5586
99%
Parameter
Source: Ph 1 GALE-401 Study ANA 105
32
32
Leadership Team
" 
Mark J. Ahn, Ph.D., President & CEO, Genentech, Amgen, Hana Biosciences,
Bristol Myers Squibb.
" 
Remy Bernarda, VP, Marketing & Communications, Hana Biosciences,
Goldman Sachs
" 
Gavin Choy, PharmD, Senior Vice President, Clinical Operations, Astex,
Hana Biosciences, Gilead, Stanford University Medical Center
" 
Ryan Dunlap, CPA, VP & CFO, Moss Adams, Nike, KPMG,
PricewaterhouseCoopers.
" 
Brian L. Hamilton, MD, PhD, EVP & Chief Medical Officer, Astra Zeneca,
Onyx Pharmaceuticals, Ziopharm, Wyeth, Alkermes, Astra
" 
Chris Lento, VP, Sales & Commercial Operations, Genentech, US Oncology,
Abraxis.
" 
Hana B. Moran, Ph.D., VP, Regulatory Affairs & Quality Assurance, Hana
Biosciences, SangStat Medical Corp, Intarcia, Scios, J&J, Elan.
" 
Pat Murphy, VP, Regulatory Affairs, Nektar Therapeutics, Bayhill
Therapeutics, Berlex, Serono, Parexel
" 
Mark W. Schwartz, Ph.D. EVP & COO, Apthera, Bayhill Therapeutics, Calyx
Therapeutics, Trega Biosciences, Incyte Genomics, DuPont Diagnostics.
33
Financial Overview
Cash, Cash Equivalents,
Marketable Securities (30 Sept 13)
3Q, 2013 Net Revenue
$55.8 million
$1.2 million
Debt
$10 million
Projected Quarterly Burn
$6-8 million
Shares Outstanding (30 Sept 13)
105 million
Market Cap (7 Feb 14)
$515 million
34
2014 Milestones
Abstral® (fentanyl) Sublingual
Tablets
•  Achieve $8-$12 million in Net
Revenues
•  Enroll 1000 patients in RELIEF
Trial
NeuVax™ (nelipepimut-S)
ü  Expand partnerships outside U.S.
•  Complete enrollment in Phase 3
PRESENT trial
•  Complete enrollment of Phase 2b
combination trial
GALE-301 (FBP)
ü  Initiate Phase 2
•  Report Phase 1 data
•  Complete Phase 2 enrollment
GALE-401 (anagrelide CR)
•  Initiate Phase 2 in Essential
Thrombocythemia
35
“I've had several friends who've had (breast cancer) and
then…it came back and they had to go through treatment
again. So this would be wonderful, not to have to come
back.”—First NeuVax Phase 3 patient
Source: E75 vaccine's final tests start in S.A. By Don Finley, January 22, 2012
http://www.mysanantonio.com/news/local_news/article/E75-vaccine-s-final-tests-start-in-S-A-2653101.php#ixzz1mJkcuHUQ
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NASDAQ: GALE
www.galenabiopharma.com
37

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